Implementing laboratory computerized systems in pharmaceutical industry : regulatory compliance

Peklaj, Kristian (avtor), Cerovšek, Mitja (avtor)

The implementation of computerized systems in pharmaceutical industry must meet the compliance with regulatory requirements, assure high level of data integrity (DI) and product quality. This study reviews European legislation, the European and U.S. pharmacopoeias, and global guidelines, such as GAMP 5 and ALCOA++, to identify the necessary standards and best practices. Key directives of European and U.S legalisation emphasize the importance of system validation, quality risk management and secure data handling. The study highlights validation processes categorized by system complexity according to GAMP 5. Additionally, guidelines like ALCOA++ provide a robust framework for achieving DI throughout the data lifecycle. By adhering to these requirements, pharmaceutical manufacturers can ensure regulatory compliance, maintain high-quality standards and safeguard patient safety.

• Jezik: Angleški jezik
• Ključne besede: compliance, computerized systems, data integrity, GAMP 5, regulations, pharmacy, validation
• Vrsta gradiva: Članek v reviji
• Tipologija: 1.01 - Izvirni znanstveni članek
• Organizacija: FS - Fakulteta za strojništvo
• Status publikacije: Objavljeno
• Različica publikacije: Objavljena publikacija
• Leto izida: 2025
• Št. strani: Str. 26-32
• Številčenje: Letn. 31, št. 1
• PID: 20.500.12556/RUL-167819
• UDK: 615:34
• ISSN pri članku: 1318-7279
• COBISS.SI-ID: 228730115
• Datum objave v RUL: 13.03.2025

Gradivo je del revije

• Naslov: Ventil : revija za fluidno tehniko in avtomatizacijo
• Skrajšan naslov: Ventil
• Založnik: Univerza v Ljubljani, Fakulteta za strojništvo
• ISSN: 1318-7279
• COBISS.SI-ID: 54233856

Licence

• Licenca: CC BY 4.0, Creative Commons Priznanje avtorstva 4.0 Mednarodna
• Povezava: http://creativecommons.org/licenses/by/4.0/deed.sl
• Opis: To je standardna licenca Creative Commons, ki daje uporabnikom največ možnosti za nadaljnjo uporabo dela, pri čemer morajo navesti avtorja.

Sekundarni jezik

• Jezik: Slovenski jezik
• Naslov: Regulativna skladnost ob implementaciji laboratorijskih računalniških sistemov v farmacevtski industriji